The present disclosure relates to recipient verification and mechanical barrier systems, for example patient blood transfusion safety systems. More particularly, it relates to a recipient verification system capable of blocking handlers from accessing contents of a vessel without first entering a unique, recipient-specific code.
The need to assign a unique code or other identifier to a person or thing (collectively referred to as a “recipient”) and subsequently employ the identifier in correlating other articles or activities to the recipient arises in a number of contexts. For example, positive patient identification is a critical step in providing medical treatment to patients in a caregiver environment (e.g., hospital). Commonly, an identification band is issued to the patient at the time of admission to the caregiver institution, and is worn by the patient at all times (e.g., a flexible plastic wristband or ankle band). The so-issued identification/admission band typically displays (e.g., printed or labeled) patient-related information, such as name, date of birth, etc. In some instances, a unique patient identifier or other code is assigned to the patient and is displayed on the band, including, for example, bar code or numeric/alphanumeric code. The patient identifier can alternatively be supplied on a separate band (apart from the admission band), and is used to cross-reference other caregiver-related items with the patient via, for example, an electronic data base. The unique patient identifier provides an independent, physical link to the patient. For example, paperwork or other caregiver documents/medical charts relating to the patient may include the patient identifier. In addition, the patient identifier can be applied to specimen samples (e.g., test tubes for blood specimens) taken from the patient, or applied to therapeutic material(s) to be given to the patient (e.g., blood donor units to be transfused), to better ensure that these and other items are accurately associated with the correct patient at all stages of the patient's visit with the caregiver institution. Along these same lines, similar recipient verification needs arise apart from hospital admission, for example blood banks, pharmacies, trauma centers, etc.
Upon issuance of therapeutic materials to be administered to the patient, the caregiver must accurately verify a match between the patient identifier on the therapeutic material(s) (e.g., either hand written on the materials or applied to the materials via an adhesive label) and the patient identifier on the intended recipient (e.g., affixed to the patient via a flexible plastic wristband or ankle band). This final recipient verification step is prone to error and can also be accidentally omitted from the process, thus allowing the administration of therapeutic materials to an incorrectly or unverified recipient.
Due to the error prone nature of this final recipient verification step, there is a need for a more active system to encourage the caregiver to match the patient identifier on the therapeutic materials and the patient. Current active systems either rely on electronic or manual systems. Both electronic and manual systems can incorporate a mechanical barrier system to restrict access to the therapeutic materials until a correct match of the patient identifier on both the patient and the therapeutic materials has been completed. Each type of system has unique advantages.
Manual recipient verification and mechanical barrier systems utilize a manual matching process where a human user must read and comprehend the codes and then confirm the match by performing an action (e.g., entering the patient identifier in to the mechanical barrier interface) before they can access the therapeutic materials to administer to the patient. This is currently accomplished by placing the therapeutic materials into a plastic polybag and then applying a mechanical combination lock to the opening of the bag to block access to the contents. Existing manual recipient verification and mechanical barrier systems provide a standalone system that can be accessed with no special tools or need for electricity or computer network connectivity.
The drawback of these current standalone manual systems is that the total number of unique patient identifier codes they are able to offer is limited by the number of code characters physically printed on the combination lock. Increasing the number of unique patient identifier codes available in the system before repeating codes increases the size of the combination lock and increases the complexity of the user interface. For example, current locks with a 3 alphabetic character code require a user to “dial in” each of those 3 characters to open the lock. If there are 24 characters to choose from and the lock is comprised of 3 wheels to enter the combination, each wheel would then have 24 characters. If it was desired to add a fourth character to the code, it would therefore be required to add a fourth wheel to the lock mechanism, again with all 24 characters on that fourth wheel. Thus, the total number of available codes for such a system is the same as the total number of physical combinations for the lock (in this case (characters)^(wheels)=24^3=13,824 unique codes in system).
Electronic recipient verification systems utilize elaborate electronics and software to automatically complete the verification of the patient identifier and thusly can provide a much greater number of unique codes because the user is not required to actually read the code or to manually enter the characters into the system to remove the mechanical barrier lock assembly and access the therapeutic materials. This approach results in a system that has a very large number of unique codes available, but also opens up the system to other issues. Electronic systems can require a complex system of networked computers, thus complicating the installation and adoption of such systems. In addition to the base technology needed for these systems there can also be issues of unplanned system downtime due to electrical power outages, lack of computer network connectivity and other causes that force the user to still have a manual process as a backup.
In light of the above, a need exists for a mechanical barrier recipient verification system exhibiting simplicity and low technology integrating cost and logistics of the manual system combined with the larger number of unique patient identifier codes than previously available in manual systems in a mechanism with no frangible component to be disposed of when initially setting the combination in to the lock. The system provides a simple-to-use lock assembly that functions in all situations, even electrical power outages.